RecruitingNot ApplicableNCT06978127

Technology Assisted Collaborative Care Intervention to Improve Patient-centered Outcomes in Dialysis Patients

Technology Assisted Collaborative Care Intervention (TĀCcare) 2.0 Implementation Trial to Improve Patient-centered Outcomes in Patients on Hemodialysis


Sponsor

University of Pittsburgh

Enrollment

424 participants

Start Date

Aug 28, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this study is to learn if a collaborative care intervention of pharmaco-therapy and/or cognitive behavioral therapy (CBT), delivered in a real-world setting, improves symptoms of pain, fatigue and/or depression.


Eligibility

Min Age: 18 Years

Inclusion Criteria15

  • Eligibility Criteria:
  • age 18 years or older;
  • undergoing thrice-weekly maintenance hemodialysis (HD) for \> 3 months;
  • English or Spanish speaking;
  • able to provide informed consent
  • Ineligibility Criteria:
  • active thought disorder, delusions or active suicidal ideation
  • active substance abuse
  • enrolled in hospice or life expectancy \< 6 months (based on clinician's judgement)
  • too ill or cognitively impaired to participate based on renal provider's judgement
  • living kidney transplant scheduled in \<3 months
  • undergoing active cancer treatment.
  • enrolled in another research study
  • plan to transition to home dialysis within 3 months
  • plan to move to another dialysis facility within 3 months

Interventions

BEHAVIORALTechnology Assisted Stepped Collaborative Care

The TĀCcare 2.0 intervention will provide pharmacotherapy recommendations and/or CBT for pain, fatigue and depression. A stepped-treatment approach will be used to intensify treatment. CBT will be provided through 12 weekly telehealth sessions (done during dialysis treatment or from home) with the behavioral specialist. Booster sessions will be used to enhance the maintenance of effect following the initial intervention to complete a total 12 month intervention. A collaborative care approach will be used so that patients' symptom management will be integrated with their dialysis treatment. Throughout the study, participants will be asked to complete phone surveys about their symptoms and health.

OTHERUsual Care Arm

Participants in the Usual Care Arm will continue with their usual care.


Locations(2)

UNM

Albuquerque, New Mexico, United States

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

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NCT06978127


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